Access to information is a central
component of compliance strategy
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2014 BSI.
BSI. All
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ACCESS TO
INFORMATION
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ACCESS TO
INFORMATION
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Compliance Navigator
delivers the right information…
at the right time…
to help you make the right decision
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So managing risk and
staying compliant is easier
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Let Compliance Navigator
do the hard work for you
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What is Compliance Navigator?
Tailored to the specific needs of regulatory affairs, quality assurance, product designers
and engineers, Compliance Navigator is a unique, user-friendly tool that allows you to
manage the compliance needs of new and existing medical device products in your
portfolio and development pipelines.
With Compliance Navigator you’ll be able to:
•
Manage the regulatory profile of your whole product portfolio at product level
•
Discover applicable compliance requirements for specific devices with our simple,
intuitive guided search
•
Assess the impact of changes on specific devices with less investment in time
and effort
•
Gain a long-term view of forthcoming changes that may affect the compliance of
individual products.
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What information is available ?
The Compliance Navigator content set comprises approximately 2,150 documents:
•
The medical devices directives (Medical Devices Directive, Active Implantable Medical Devices
Directive, In Vitro Diagnostic Devices Directive)
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Title 21, Part 800 of the Code of Federal Regulations (CFR)
•
MEDDEVs (guidance published by the European Commission in relation to the directives)
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Harmonized and consensus standards relating to the directives and the CFR
•
All BSI standards (including EN, ISO, IEC, CLC) which fall under ICS code 11 (Health care
technology), excluding 11.220 (veterinary medicine)
•
All BSI standards which are mandated under the Directives
•
All BSI standards which emanate from healthcare committees
•
Selected FDA Guidance documents, based on reference from the list of consensus standards
•
Metadata and related front matter (scope, contents, etc.) for relevant ASTM and AAMI standards
(>500 documents) and a link to purchase from the BSI shop or AAMI store
•
Selected expert commentary and redlined files on key standards
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Organize your compliance
information according to
product…
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Search across Compliance
Navigator by device type
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Use the semantic search to
explore related devices
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…and, within each product,
according to subject
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Plan ahead for forthcoming changes
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Track changes between
versions of standards,
and benefit from
exclusive expert
commentary
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Notifications
An automatic email “push notification” will also be sent to each user.
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In summary:
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Find out more
See a demo today
bsigroup.com/complinav
mark.flanick@bsigroup.com
@BSIStandards
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Compliance Navigator demo
https://www.youtube.com/watch?v=MzDBAnrfCPo
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